NCT07732400 A Study of VV-14303 for the Treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH)
| NCT ID | NCT07732400 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Kriya Therapeutics, Inc. |
| Condition | Metabolic Dysfunction-associated Steatohepatitis (MASH) |
| Study Type | INTERVENTIONAL |
| Enrollment | 56 participants |
| Start Date | 2026-07-30 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 56 participants in total. It began in 2026-07-30 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A Study of VV-14303 for the Treatment of Metabolic dysfunction-associated steatohepatitis (MASH)
Eligibility Criteria
Inclusion Criteria: * Participant is capable of providing signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol * Must be 18 to 75 years of age (inclusive) at Screening * Body Mass Index (BMI) of 25 to \<40 kg/m2 (inclusive) * Male participants must agree to use a highly effective contraception during the Treatment Period and at least 12 months after administration of VV-14303. Female participants must not be a woman of child-bearing potential (WOCBP) * Biopsy-confirmed MASH * Previous history or presence of ≥2 of the following metabolic risk factors: obesity (BMI ≥25 kg/m²), hypertension (blood pressure \[BP\] ≥140/90 mmHg or on antihypertensive medication), dyslipidemia (triglycerides ≥150 mg/dL or high-density lipoprotein cholesterol \[HDL-C\] \<40 mg/dL in men/\<50 mg/dL in women or on lipid-lowering therapy), type 2 diabetes mellitus * Must be willing to refrain from the donation of blood, plasma, platelets, eggs, or sperm during the 12-month post-treatment follow-up period Exclusion Criteria: * Presence of alternate and/or additional liver disease etiologies at Screening, including but not limited to chronic viral hepatitis, autoimmune hepatitis * Use of treatments for metabolic syndrome management, including oral antidiabetic drugs (OADs) (e.g., metformin), incretin mimetics (GLP-1 receptor agonists or GLP-1/gastric inhibitory polypeptide \[GIP\] agonists) or other glucose-lowering agents that has not been stable for at least 6 months prior to Screening * Use of Resmetirom that has not been stable for at least 6 months prior to Screening visit * Any medical, cognitive, or psychiatric condition that, in the opinion of the Investigator, could contraindicate the use of the investigational drug, make consistent study assessment and follow-up over the 12-month Post-Treatment Follow-up Period unlikely, or would make the participant an unsafe study candidate. * Type 1 diabetes, or poorly controlled type 2 diabetes (HbA1c \> 8.0% at Screening) * History of major trauma to the muscle(s) intended for IM injection meeting any of the following criteria: 1. Within 6 months prior to Screening, or 2. At any timepoint prior to Screening with continued neurologic or musculoskeletal symptoms * Prior participation in any systemic experimental treatment or receiving any other systemic investigational treatment including within 6 weeks or 5 half-lives of the active ingredient (whichever is longer) prior to the start of Screening * Any vaccination or planned vaccination 30 days prior to dosing, or planned vaccination 8 weeks post dosing * Previously received AAV or adenoviral therapy or participation in any previous gene therapy trial
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07732400 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Metabolic Dysfunction-associated Steatohepatitis (MASH). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07732400 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07732400 currently recruiting?
Yes, NCT07732400 is actively recruiting participants. Contact the research team at clinicaltrials@kriyatx.com for enrollment information.
Where is the NCT07732400 trial being conducted?
This trial is being conducted at Chandler, United States, Lady Lake, United States, Auckland, New Zealand.
Who is sponsoring the NCT07732400 clinical trial?
NCT07732400 is sponsored by Kriya Therapeutics, Inc.. The trial plans to enroll 56 participants.